Assessment of the effectiveness of additional Risk Minimisation Measures (aRMMs) among pharmacists for provision of desogestrel 75 microgram tablets in a community pharmacy setting

Study identification

• EU PAS number:
  EUPAS43307
• Study ID:
  47418
• Official title and acronym:
  Assessment of the effectiveness of additional Risk Minimisation Measures (aRMMs) among pharmacists for provision of desogestrel 75 microgram tablets in a community pharmacy setting
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom (Northern Ireland)
• Study description:
  Desogestrel 75 microgram tablets was reclassified to a pharmacy only (P) medicine in the UK separately by Maxwellia Ltd and HRA Pharma in July 2021. To support the safe supply of the products via pharmacy, both companies have independently developed a Pharmacy Training Guide and an optional Pharmacy Checklist as additional Risk Minimisation Measures (aRMMs). The training materials and consultation checklists together constitute important aRMMs for the non-prescription supply of the products, so that an appropriate decision is made by pharmacists to supply patients and correct advice is given. The content of the materials is aligned and has been agreed with the MHRA. The overall objective of this study is to evaluate the effectiveness of the aRMMs in mitigating the risks of incorrect supply of desogestrel 75 microgram tablets to patients in a community pharmacy.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:26/02/2021

Actual:26/02/2021

Study start date

Planned:10/01/2022

Actual:20/01/2022

Date of final study report

Planned:18/04/2022

Actual:22/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

HRA Pharma, Maxwellia Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CIG030921