Analysing the landscape for prescription to non-prescription reclassification (switch) in Germany: an interview study of committee members and stakeholders.

Publisher: BioMed Central Country of Publication: England NLM ID: 101088677 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6963 (Electronic) Linking ISSN: 14726963 NLM ISO Abbreviation: BMC Health Serv Res Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Nonprescription Drugs/*classification ; Prescription Drugs/*classification; Committee Membership ; Germany ; Humans ; Qualitative Research ; Stakeholder Participation

Background: Non-prescription medicines are increasingly used in Germany, aided by prescription-to-non-prescription reclassification (or switch). This study aimed to examine the barriers and enablers to reclassification of medicines in Germany and provide recommendations for change.
Methods: Face-to-face conversational interviews with purposively selected key informants in Germany were conducted in 2017 by a researcher informed in the area. Interviews were transcribed, coded in NVIVO and systematically analysed using a framework approach.
Results: Twenty-four interviews were conducted with 32 participants including members of the committee considering reclassifications, and representatives from government, industry, health insurance, academia, and pharmacy, medical, and patients' organisations. A range of enablers and barriers emerged that influence reclassification including effects on the committee and process, or the desire of pharmaceutical companies to pursue reclassifications. Enabling market factors included the large population and a culture of self-medication. Enabling health system factors include the pharmacy-only category. Some pharmacy factors appeared enabling (e.g. a positive experience after reclassifying emergency contraception) while others appeared to hinder reclassification (e.g. insufficient pharmacy practice research). Some medical factors were enabling (e.g. reported waiting times) and others limited reclassification (e.g. opposition to some reclassifications). Some committee and government openness to reclassification and self-medication reportedly enabled reclassification, while conservatism was considered a barrier, particularly for classifications with special conditions for supply such as initial doctor diagnosis or other complexities. Some improvements to the committee constitution and considerations were recommended. Some participants found the reclassification process after the committee recommendation opaque, with opportunity for delays and political interference. Industry factors included both enablers such as capability in reclassification, and barriers, such as a perceived low market potential of some reclassifications, and doubt that some candidates would be approved. A need for more data emerged strongly, both pre-reclassification in applications, and post-reclassification. Many participants saw merit with reclassification in non-traditional areas such as hypertension, diabetes and oral contraception.
Conclusions: Many factors influence reclassification in Germany. Recommended improvements included aspects of the process and committee consideration, and more data collection. Sufficient market exclusivity linked to data collection could aid the generation of evidence to aid committee considerations and encourage more applications of high quality.

BMJ. 2000 Jan 8;320(7227):114-6. (PMID: 10625273)
N Engl J Med. 2001 Jun 28;344(26):2021-5. (PMID: 11430334)
N Engl J Med. 2001 Sep 13;345(11):810-6. (PMID: 11556302)
Clin Ther. 2006 Aug;28(8):1231-1243. (PMID: 16982301)
Health Policy. 2008 Apr;86(1):17-26. (PMID: 17935827)
Health Expect. 2009 Mar;12(1):106-15. (PMID: 19250156)
J Clin Pharmacol. 2012 Aug;52(8):1277-83. (PMID: 21908879)
PLoS One. 2014 Sep 24;9(9):e107726. (PMID: 25251434)
PLoS One. 2015 Mar 18;10(3):e0119011. (PMID: 25785589)
J Health Serv Res Policy. 2015 Oct;20(4):231-9. (PMID: 26152909)
Eur J Clin Pharmacol. 2015 Nov;71(11):1389-96. (PMID: 26300207)
Eur J Clin Pharmacol. 2017 Jul;73(7):901-910. (PMID: 28352949)
BMC Health Serv Res. 2018 Mar 20;18(1):191. (PMID: 29558925)
Int J Clin Pharm. 2018 Jun;40(3):650-658. (PMID: 29605946)
Ther Innov Regul Sci. 2013 Jan;47(1):32-40. (PMID: 30227490)
Res Social Adm Pharm. 2019 Apr;15(4):387-394. (PMID: 30917892)

n/a Bundesverband der Arzneimittel-Hersteller

Keywords: Access to medicines; Health policy; Medicines regulation; Nonprescription drugs; Reclassification; Self medication

0 (Nonprescription Drugs)
0 (Prescription Drugs)

Date Created: 20190622 Date Completed: 20190906 Latest Revision: 20200225

20221213

PMC6587299

10.1186/s12913-019-4219-6

31221154