Prescribing of Opioids in Menopausal and Postmenopausal Women in the UK: A Population-based Drug Utilization Study

Study type
Protocol
Date of Approval
Study reference ID
23_003150
Lay Summary

The typical age when women in the United Kingdom (UK) lose their period is around 50 years, and symptoms associated with the end of this phase can persist for 10-20 years or more. A recent study was conducted on female veterans aged 45 to 64 in the United States (US) to understand how many of these women experience chronic pain. Approximately half (52%) reported chronic pain that significantly impacted their quality of life, with only some (22%) being formally diagnosed with an underlying chronic pain condition. Research indicates that hormonal changes during this life stage can lead to severe chronic pain, affecting daily functioning. In the UK, strategies for managing chronic noncancer pain involve the use of pain medications, both over-the-counter and prescription strength, along with non-medical remedies. The recommended intervention for general symptoms associated with the conclusion of a woman's reproductive phase, including moderate pain, is hormone replacement therapy (HRT). Many women over the age of 50 use HRT; however, it is not commonly prescribed for severe pain. In instances of intense and ongoing pain, opioids are frequently prescribed despite concerns about their long-term usage. This study seeks to describe patterns of opioid prescriptions, whether used alone or in addition to HRT, among women aged 50 to 79 who have ended their reproductive phase. Examining opioid prescription patterns will contribute to a better understanding of the management of chronic noncancer pain in women who no longer have their period across the UK, informing future risk-benefit studies and healthcare planning.

Technical Summary

We aim to describe how opioids are prescribed by physicians to women of menopausal and postmenopausal age with chronic noncancer pain throughout the United Kingdom (UK). The proposed study is a descriptive drug utilisation study, which will calculate the incidence, prevalence, and discontinuation rates of opioids, alone or in combination with HRT, using 13 years (2010 to 2023) of UK primary healthcare records (CPRD Gold and Aurum). The menopausal/postmenopausal population group will be defined by age and diagnosis for a chronic noncancer pain indication. The age range used to capture menopause and post-menopause will be defined as 50 to 79 years. A diagnosis for osteoarthritis, osteoporosis, rheumatoid arthritis, polymyalgia rheumatica, fibromyalgia, sarcopenia, and chronic low back pain/back pain will define chronic noncancer pain indications. The incidence rate (IR) of women who received their first prescription for an opioid will be calculated annually using person-years at risk (PYAR) as the denominator and 95% Confidence Intervals (CI). Relative changes in annual IR will be expressed as percentages and the average percentage change will be assessed using linear regression. Annual prescribing prevalence per 100 women will be calculated using mid-year population estimates of women aged 50-79 years with chronic noncancer pain. Kaplan Meier curves will be used to calculate the discontinuation rates for opioid use, with the end event being the date of the last prescription for the opioid medication. The discontinuation rate will show the average duration of opioid use for chronic noncancer pain management in the defined menopausal/postmenopausal population group. The calculations for incidence, prevalence, and discontinuation rates will be stratified by pain indication, ethnicity, and age group. All analyses will be descriptive and will provide information regarding the prescribing rates of opioids in the menopausal/postmenopausal population group with a chronic noncancer pain indication that can be used for future studies.

Health Outcomes to be Measured

All calculations are in relation to the prescription for opioids, alone or in combination with HRT: Incidence; Prevalence; Discontinuation Rates (Kaplan Meier Curves)

Collaborators

Ruth Brauer - Chief Investigator - University College London ( UCL )
Emma Tillyer - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )

Former Collaborators

Ruth Brauer - Collaborator - University College London ( UCL )

Linkages

CPRD Aurum Ethnicity Record;CPRD GOLD Ethnicity Record