Study identification

PURI

https://redirect.ema.europa.eu/resource/32208

EU PAS number

EUPAS27346

Study ID

32208

Official title and acronym

Survey of pharmacists to evaluate the effectiveness of the Viagra Connect national additional Risk Minimisation Measure (aRMM) in the United Kingdom (UK) (NA)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This study will be conducted per request of the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency). The study will be a cross sectional, non interventional web based survey that will be conducted among pharmacists in the UK. The objective of the study is to evaluate the effectiveness of the Viagra Connect national aRMMs (i.e. the pharmacist training guide and the checklist) by assessing: • The pharmacists’ knowledge of the key risk messages contained in the Viagra Connect training materials, • The pharmacists’ participation in the Viagra Connect pharmacist training,• The pharmacists’ utilisation of the optional Viagra Connect Pharmacy Checklist at the point of dispensing. Pharmacists must meet all of the following inclusion criteria to be eligible for inclusion in the study:• Willing/consent to participate in this self administered survey, • A practicing pharmacist in the UK, • Received at least one patient face-to-face request to supply Viagra Connect in the past six months.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Joanna (Asia) Lem

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Study protocol
Initial protocol

Viagra Connect_A1481334_PASS_Pharmcist Survey_Protocol_Redacted for ENCeP registration

English (1019.05 KB - PDF)View document
Updated protocol

A1481334_FINAL PROTOCOL AMENDMENT 2 (V.1.2)_13JUNE2018

English (2.15 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable