Domperidone for insufficient lactation: a drug utilization study with interrupted time-series analysis

Study type
Protocol
Date of Approval
Study reference ID
16_178
Lay Summary

The use of domperidone to increase milk production (lactation) among women experiencing difficulties breastfeeding is increasing. In the province of British Columbia, Canada, 18% of women used domperidone in the year following delivery in 2011, up from 7.5% in 2002. In Australia, the proportion of women using domperidone for insufficient lactation rose from less than 1% in 2000 to approximately 5% in 2010. The purpose of this study is to describe the prescribing practices of domperidone following childbirth in terms of the characteristics of the women receiving prescriptions, and of the dosage of domperidone, length of time prescribed, and the co-prescribing of medications capable of causing abnormalities in heart rhythm. In addition, we will examine whether prescriptions of domperidone after childbirth decreased following a recommendation to restrict its usage due to concerns of an increased risk of heart attack deaths associated with its use. This study will be conducted using de-identified information from general practitioner records (the Clinical Practice Research Datalink) and hospital based medical records. Findings from this research will help healthcare providers better understand the use of domperidone to promote lactation.

Technical Summary

The purpose of this study is to describe the prescribing practices of domperidone for insufficient lactation in terms of the demographic, obstetric, and medical profile of the women receiving prescriptions, and domperidone dosage, length of time prescribed, and the co-prescribing of medications capable of causing abnormalities in heart rhythm. In addition, we will determine whether prescriptions of domperidone decreased following a recommendation to restrict its usage. We will conduct a retrospective cohort analysis of women who delivered a live birth between April 1, 2002 and March 31, 2015 using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics. We will use information recorded by general practitioners about domperidone prescriptions written for women in the year following childbirth and obstetric characteristics will be based on information recorded during the birth hospitalization and medical records during the pregnancy. We will describe the patterns of prescription of domperidone postpartum and compare the characteristics of women using domperidone to women not using the medication. Interrupted time series analyses will be used to determine whether prescribing of domperidone decreased following a recommendation restricting the use of domperidone due to concerns about a potential increased risk of heart attack deaths associated with its use.

Health Outcomes to be Measured

Domperidone prescriptions up to one year following childbirth (prevalence, dose, timing and duration)

Collaborators

Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Adrian Root - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Azar Mehrabadi - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation