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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Non-interventional web-based survey

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DESOGESTREL
• Anatomical Therapeutic Chemical (ATC) code:
  (G03AC09) desogestrel

  desogestrel
• Medical condition to be studied:
  Oral contraception

Population studied

• Short description of the study population:
  Inclusion Criteria ; All respondents invited to participate will be qualified pharmacists working in community pharmacies in the UK, will have read at least one of the aRMM materials and held at least one consultation with a female customer regarding the supply of desogestrel 75 microgram tablets in the previous six months. The sample will aim to be representative of community pharmacists by age, gender, outlet size, and by region within the UK, including Northern Ireland. Respondents will be invited to participate on the basis that they meet and confirm their acceptance of the inclusion criteria:; • Their information will only be used for research purposes and will not be passed to any other organisation without their permission;; • They have the right to refuse to answer questions or withdraw at any time. They consent to CIG Research collecting and using the information that they voluntarily provide for the purposes of research;; • They understand that if they become aware of any AEs during the course of the study, they will report these to CIG Research, who will pass their comments to the client about whose products they relate. They may choose to have these passed on anonymously or with their contact details, which will be collected at the end of the survey.; ; Exclusion Criteria; Pharmacists will not be included in the study if they:; • Have not received and read the aRMM materials supplied for the products in the UK, or do not recall having received or read them;; • Have participated in the user testing of the draft questions for the survey; • Are employed in full-time research, GP practices or hospitals (i.e. not community-based pharmacists);; • Work only as online pharmacists and do not provide consultations;; • Are in the employment of or are contracted to the MHRA, Maxwellia Ltd, Laboratoire HRA Pharma, Communications International Group or Consensio LLP.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To evaluate the effectiveness of desogestrel 75 microgram tablets adiitional Risk Minimisation Measures
• Outcomes:
  Demonstrate that the training is effective in enabling pharmacists to make appropriate decisions to supply based on contraindications and special warnings, Identify whether there are particular contraindications or warnings for which pharmacists consistently make wrong supply decisions, Establish ease of access to and ease of use of the aRMMs
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% confidence intervals (CIs) will be calculated for pharmacist’s responses to all questions that address the survey objectives.